Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic … (NCT06823258) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function
32 participantsStarted 2025-02-28
Plain-language summary
This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and be willing to strictly follow the clinical study protocol to complete this study;
. The subjects agree to have no plans to conceive or donate sperm/eggs within 6 months from the signing of the informed consent form until the last administration, and voluntarily adopt effective contraceptive measures (non-pharmacological contraceptive measures were taken during the study period, as detailed in Appendix 1);
. On the day of signing the informed consent form, both males and females must be at least 18 years old;
. The weight of male subjects shall not be less than 50 kg, and the weight of female subjects shall not be less than 45 kg; Body mass index (BMI) 18-33 kg/m2 (including both ends);
. Creatinine clearance rate (calculated using the Cockcroft Gault formula, see Appendix 2) ≥ 60 mL/min.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak plasma concentration (Cmax) of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
2
Pharmacokinetic parameters AUC0-t of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
3
Pharmacokinetic parameters AUC0-∞ of HS-10365
Timeframe: From the first dose (Day 0) up to Day 6
. BMI matching with the matched hepatic impairment group, with a mean within ± 15% range;
. Age matching with the matched hepatic impairment group, with a mean of ± 5 years;
. Gender matching with the matched hepatic impairment group，with the same number of individuals for each gender;
Exclusion criteria
. During the screening period, 12 lead electrocardiogram results showed QT interval prolongation (male QTcF\>470 ms; female QTcF\>480 ms);
. Individuals at increased risk of QT interval prolongation (such as heart failure, congenital long QT syndrome, family history of long QT syndrome, refractory hypokalemia, or unexplained sudden death in immediate family members under 40 years old);
. Individuals who have previously suffered from cardiovascular diseases (such as organic heart disease, myocardial infarction, angina pectoris, arrhythmia, etc.) and are deemed unsuitable for inclusion by the researchers;
. Severe or poorly controlled hypertension, including a history of hypertensive crisis or hypertensive encephalopathy; Within 2 weeks prior to the first administration, adjustments were made to antihypertensive medication due to poor blood pressure control; During the screening period, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg;
. Those who have difficulty swallowing or have undergone surgery that may affect drug absorption, distribution, metabolism, and excretion, and are deemed unsuitable for inclusion by the researchers;
. Individuals who are prone to allergic reactions or have an allergic constitution (such as those who are allergic to pollen, two or more drugs/foods), or those who are known to be allergic to the study drug or any component of the study drug;
. Individuals who have participated in any other clinical trials within the previous 3 months and have used study drugs or plan to participate in other clinical trials during the study period (those who have not been given the study drug or placebo after enrollment may be included);
. Individuals who have donated blood or lost blood ≥ 400 mL within the first 3 months of screening, or have received blood transfusions or used blood products, or intend to donate blood during the trial period or within 1 month after the trial ends;